Many pharmaceutical formulations and reagents used in diagnostic evaluations are sensitive to oxygen and/or moisture. Exposure of such pharmaceutical formulations and reagents to oxygen may interfere with the stability and efficacy of the pharmaceutical agent or reagent.
The importance of providing pharmaceutical formulations in which an oxidation-susceptible active drug is protected against oxidative degradation, in particular, with prolonged storage or storage at elevated temperatures, is a concept well known to, and appreciated by, members of the pharmaceutical industry. Preservatives and antioxidants are often employed in the pharmaceutical formulation to address this problem.
Oxygen scavengers or displacement of oxygen with an inert gas in the headspace of a finished product has been used to reduce the generation of oxidative degradation products.
Degradation protectants for increasing the shelf-life of medical devices are described for example in U.S. Pat. No. 6,660,295 and United States Patent Publication Nos. 20010051180; 20040187438; and 20070084144. Oxygen scavenging packaging for pharmaceuticals and other oxygen sensitive products are described for example in United States Patent Publication Nos. 20020155233 and 20060076536.
Oxidative degradation of sufentanil has not been reported for liquid (Sufenta) or dry powder forms of sufentanil (Janssen Pharmaceuticals, and Johnson Matthey, Inc.). Surprisingly, oxidative degradation of sufentanil in low dose solid dosage forms prepared using aqueous and/or organic solvents has been observed.
There remains a need for development of specific pharmaceutical formulations and packaging systems to ensure that oxidation-susceptible drugs, such as sufentanil, can be formulated and stored in low dose solid dosage forms in a manner where oxidative degradation is minimized and the integrity of the active drug is maintained.